QC Chemistry Group Lead

PCI Pharma Services•San Diego, CA

4d•Onsite

About The Position

The QC Chemistry Group Lead ensures the fundamental integrity of the laboratory infrastructure. This position oversees routine and non-routine analysis of proteins, peptides, small molecules, large molecules, and ADCs, and supports the development of procedures & initiatives to reach departmental goals.

Requirements

Associate’s Degree or equivalent required.
Minimum of 4 years of relevant experience in quality control.
Minimum of 1 year of functional or day to day leadership experience.
Working knowledge and experience with GMP regulations, good documentation practices, troubleshooting, and data entry.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Demonstrated ability to follow detailed directions in a laboratory environment.
Must be proficient with Microsoft Office applications.

Nice To Haves

Bachelor’s degree in a Life Sciences discipline strongly preferred.
Experience with electronic Quality Systems preferred.

Responsibilities

Leads and/or collaborates on method establishment (e.g. method verification, qualification, transfers and validations) for compendial assays and other chemistry methods.
Performs routine analysis and testing for compendial assays such as pH, osmolality, extractable volume, density, particulate matter, HVLD and appearance, as well as ELISA, CE-SDS, SDS-PAGE, viscosity and moisture content.
Provides scientific direction and technical problem solving to team members and internal stakeholders.
Interacts with clients and follows up on client inquiries.
Reviews data, technical reports, deviations, OOS investigations and test results and provides conclusions and proposals for future directions.
Technical writing of investigations for deviations and out of specification reports.
Ensures the maintenance of laboratory instrumentation.
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
Engages employees by creating a climate in which they want to do their best.
Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Maintains employee work schedules.
Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.